EMEA-000316-PIP02-11-M05 - paediatric investigation plan

sacubitril

valsartan

Key facts

• Invented name:
  Entresto
• Active substance:
  • sacubitril
  • valsartan
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0327/2021
• PIP number:
  EMEA-000316-PIP02-11-M05
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate solid oral formulation
• Condition(s) / indication(s):
  Treatment of heart failure
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/08/2021
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000316-PIP02-11-M05
• Compliance opinion date:
  20/05/2022
• Compliance outcome:
  Positive

Decision

P/0327/2021 : EMA decision of 13 August 2021 on the acceptance of a modification of an agreed paediatric investigation plan for sacubitril / valsartan (Entresto) (EMEA-000316-PIP02-11-M05)

Adopted Reference Number: EMA/395853/2021