EMEA-003152-PIP01-21 - paediatric investigation plan

dolutegravir

HIV-1 Maturation Inhibitor (GSK3640254)

Key facts

• Active Substance:
  • dolutegravir
  • HIV-1 Maturation Inhibitor (GSK3640254)
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0523/2022
• PIP number:
  EMEA-003152-PIP01-21
• Pharmaceutical form(s):
  • Age-appropriate oral dosage form
  • Film-coated tablet
• Condition(s) / indication(s):
  Treatment of human immunodeficiency virus (HIV-1) infection
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  ViiV Healthcare UK Limited

  E-mail: [e-mail]; Tel: [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  30/12/2023

Decision

P/0523/2022 : EMA decision of 30 December 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for HIV-1 maturation inhibitor (GSK3640254) / dolutegravir (EMEA-003152- PIP01-21)

AdoptedReference Number: EMA/929803/2022