EMEA-001695-PIP01-14-M05 - paediatric investigation plan

doravirine

lamivudine

tenofovir disoproxil (fumarate)

Key facts

• Invented name:
  Delstrigo
• Active Substance:
  • doravirine
  • lamivudine
  • tenofovir disoproxil (fumarate)
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0504/2022
• PIP number:
  EMEA-001695-PIP01-14-M05
• Pharmaceutical form(s):
  • Tablet
  • Granules
• Condition(s) / indication(s):
  Treatment of human immunodeficiency virus (HIV-1) infection
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  MSD Europe Belgium S.R.L.; E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  02/12/2022

Decision

P/0504/2022: EMA decision of 2 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for doravirine / lamivudine / tenofovir disoproxil (fumarate) (Delstrigo), (EMEA-001695-PIP01-14-M05)

AdoptedReference Number: EMA/876007/2022