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
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):DOLUTEGRAVIRLAMIVUDINE.pdf
Published Date 15/08/2024