EMEA-001584-PIP01-13-M07 - paediatric investigation plan

tenofovir alafenamide fumarate

Key facts

• Invented name:
  Vemlidy
• Active substance:
  tenofovir alafenamide fumarate
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0386/2023
• PIP number:
  EMEA-001584-PIP01-13-M07
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate non-tablet formulation
• Condition(s) / indication(s):
  Treatment of chronic viral hepatitis B
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  07/09/2023
• Compliance check done:
  Non

Decision

P/0386/2023: EMA decision of 7 September 2023 on the acceptance of a modification of an agreed paediatric investigation plan for tenofovir alafenamide (Vemlidy), (EMEA-001584-PIP01-13-M07)