EMEA-000316-PIP03-20 - paediatric investigation plan

sacubitril

valsartan

Key facts

• Invented name:
  Entresto
• Active substance:
  • sacubitril
  • valsartan
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0315/2020
• PIP number:
  EMEA-000316-PIP03-20
• Pharmaceutical form(s):
  • Age appropriate oral solid dosage form
  • Film-coated tablet
  • Granules
• Condition(s) / indication(s):
  Prevention of heart failure
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  14/08/2020
• Compliance check done:
  Níl

Decision

P/0315/2020 : EMA decision of 14 August 2020 on the granting of a product specific waiver for sacubitril / valsartan (Entresto and associated names) (EMEA-000316-PIP03-20)

Adopted Reference Number: EMA/413747/2020