MHRA-100543-PIP01-22-M03 (update)

Key Facts

Active Substance
  • DOLUTEGRAVIR
  • LAMIVUDINE
Invented Name
  • Dovato
  • Dovato
  • Dovato
PIP Number MHRA-100543-PIP01-22-M03 (update)
Pharmaceutical form(s)
  • Film-coated tablet
  • Dispersible 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
  • ViiV Healthcare UK Limited
  • Country United Kingdom
  • Tel +4402080475000
  • 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
Yes
Compliance Check Decision Date
Compliance opinion date
06/05/2025
Compliance Check Procedure Number
Compliance procedure number
MHRA-100543-PIP01-22-M03-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):DOLUTEGRAVIRLAMIVUDINE.pdf
Published Date 01/05/2026