MHRA-101174-PIP01-23

Key Facts

Active Substance
Active Substance:
  • LENACAPAVIR SODIUM
Invented Name
  • Sunlenca
  • Sunlenca
PIP Number MHRA-101174-PIP01-23
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
  • 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
13/02/2025
Compliance Check Procedure Number
Compliance procedure number
MHRA-101174-PIP01-23-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):LENACAPAVIR SODIUM.pdf
Published Date 13/11/2025