EMEA-000671-PIP01-09-M10 - paediatric investigation plan

sildenafil

Key facts

• Invented name:
  • Revatio
  • Revatio
• Active Substance:
  sildenafil
• Therapeutic area:
  Other
• Decision number:
  P/0016/2019
• PIP number:
  EMEA-000671-PIP01-09-M10
• Pharmaceutical form(s):
  • Film-coated tablet
  • Powder for oral solution
  • Solution for injection
• Condition(s) / indication(s):
  Treatment of pulmonary arterial hypertension
• Route(s) of administration:
  • Oral use
  • Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  03/01/2019
• Compliance procedure number:
  EMEA-C-000671-PIP01-09-M10
• Compliance opinion date:
  20/09/2019
• Compliance outcome:
  Positive

Decision

P/0016/2019: EMA decision of 3 January 2019 on the acceptance of a modification of an agreed paediatric investigation plan for sildenafil (Revatio), (EMEA-000671-PIP01-09-M10)

AdoptedReference Number: EMA/831890/2018