EMEA-001825-PIP01-15 - paediatric investigation plan

darunavir

cobicistat

emtricitabine

tenofovir alafenamide

Key facts

• Active Substance:
  • darunavir
  • cobicistat
  • emtricitabine
  • tenofovir alafenamide
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0123/2016
• PIP number:
  EMEA-001825-PIP01-15
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age-appropriate oral solid dosage form
• Condition(s) / indication(s):
  Treatment of human immunodeficiency virus (HIV-1) infection
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  12/05/2016

Decision

P/0123/2016: EMA decision of 12 May 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for darunavir / cobicistat / emtricitabine / tenofovir alafen...

AdoptedReference Number: EMA/287464/2016