MHRA-100428-PIP01-22-M02 (update)

Key Facts

Active Substance
Active Substance:
  • LENACAPAVIR SODIUM
Invented Name
  • Sunlenca
  • Sunlenca
PIP Number MHRA-100428-PIP01-22-M02 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection , Film-coated tablet, Age-appropriate oral solid dosage form
Therapeutic area
Therapeutic area:
  • Infectious diseases
Conditions / Indications
Conditions / Indications:
  • Treatment of human immunodeficiency virus (HIV-1) infection
Route(s) of administration
  • Subcutaneous 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 SODIUM.pdf
Published Date 03/10/2024