EMEA-000774-PIP01-09-M03 - paediatric investigation plan

emtricitabine

rilpivirine hydrochloride

tenofovir disoproxil fumarate

Key facts

• Invented name:
  Eviplera
• Active substance:
  • emtricitabine
  • rilpivirine hydrochloride
  • tenofovir disoproxil fumarate
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0274/2018
• PIP number:
  EMEA-000774-PIP01-09-M03
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of human immunodeficiency virus (HIV-1) infection
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  23/08/2018
• Compliance check done:
  Ei

Decision

P/0274/2018: EMA decision of 23 August 2018 on the acceptance of a modification of an agreed paediatric investigation plan for emtricitabine / rilpivirine (hydrochloride) / tenofovir (disoproxil fumarate (Eviplera), (EMEA-000774-PIP01-09-M03)

Adopted Reference Number: EMA/537553/2018