MHRA-100351-PIP01-21-M01 (update)

Key Facts

Active Substance
  • DOLUTEGRAVIR
  • RILPIVIRINE
Invented Name
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JASUPA
  • Juluca 50mg/25mg film-coated tablets
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
PIP Number MHRA-100351-PIP01-21-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Film-coated tablet
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
  • GlaxoSmithKline UK Ltd
  • Country United Kingdom
  • Tel 02080475000
  • Email oax52639@gsk.com
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):DOLUTEGRAVIRRILPIVIRINE.pdf
Published Date 30/06/2023