EMEA-000533-PIP01-08-M11 - paediatric investigation plan

tenofovir disoproxil fumarate

Key facts

• Invented name:
  Viread
• Active substance:
  tenofovir disoproxil fumarate
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0073/2022
• PIP number:
  EMEA-000533-PIP01-08-M11
• Pharmaceutical form(s):
  • Film-coated tablet
  • Granules
• Condition(s) / indication(s):
  • Treatment of chronic viral hepatitis B
  • Treatment of human immunodeficiency virus (HIV-1) infection
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  11/03/2022
• Compliance check done:
  Ja
• Compliance procedure number:
  EMEA-C-000533-PIP01-08-M11
• Compliance opinion date:
  20/01/2023
• Compliance outcome:
  Positive

Decision

P/0073/2022 : EMA decision of 11 March 2022 on the acceptance of a modification of an agreed paediatric investigation plan for tenofovir disoproxil (Viread), (EMEA-000533-PIP01-08-M11)

Adopted Reference Number: EMA/65153/2022