MHRA-101174-PIP01-23-M01 (update)

Key Facts

Active Substance
  • LENACAPAVIR SODIUM
  • Lenacapavir
Invented Name
  • Sunlenca
  • Yeytuo
  • Sunlenca
  • Yeytuo
  • Sunlenca
  • Yeytuo
PIP Number MHRA-101174-PIP01-23-M01 (update)
Pharmaceutical form(s)
  • Solution for injection
  • Film-coated tablet
Therapeutic area
Therapeutic area:
  • Infectious diseases
Conditions / Indications
Conditions / Indications:
  • Prevention of human immunodeficiency virus (HIV-1) infection
Route(s) of administration
  • Subcutaneous use
  • Intramuscular use
  • 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
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):LENACAPAVIR SODIUMLENACAPAVIR.pdf
Published Date 14/10/2026