EMEA-001091-PIP02-15 - paediatric investigation plan

emtricitabine

tenofovir disoproxil fumarate

Key facts

• Invented name:
  • Truvada
  • Truvada
• Active substance:
  • emtricitabine
  • tenofovir disoproxil fumarate
• Decision number:
  P/0294/2015
• PIP number:
  EMEA-001091-PIP02-15
• 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:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  03/12/2015
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001091-PIP02-15
• Compliance opinion date:
  16/12/2016
• Compliance outcome:
  Positive

Decision

P/0294/2015: EMA decision of 3 December 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for emtricitabine / tenofovir disoproxil fumarate (Truvad...

Adopted Reference Number: EMA/785816/2015