MHRA-101812-PIP01-25

Key Facts

Active Substance
  • BICTEGRAVIR
  • LENACAPAVIR SODIUM
Invented Name
Not yet available
PIP Number MHRA-101812-PIP01-25
Pharmaceutical form(s)
  • Film-coated tablet
  • Age-appropriate oral solid dosage form.
Therapeutic area
Therapeutic area:
  • Infectious diseases
Conditions / Indications
Conditions / Indications:
  • Treatment of Human Immunodeficiency virus type 1 (HIV-1) 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
Yes
Compliance Check Decision Date
Compliance opinion date
18/03/2026
Compliance Check Procedure Number
Compliance procedure number
MHRA-101812-PIP01-25-C1

Decision Document

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