EMEA-003065-PIP01-21 - paediatric investigation plan

eplerenone

Furosemide

Key facts

• Active Substance:
  • eplerenone
  • Furosemide
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0488/2021
• PIP number:
  EMEA-003065-PIP01-21
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment 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:
  03/12/2021

Decision

P/0488/2021 : EMA decision of December 2021 on the granting of a product specific waiver for eplerenone / furosemide (EMEA-003065-PIP01-21)

AdoptedReference Number: EMA/632017/2021