EMEA-003289-PIP01-22 - paediatric investigation plan

eplerenone

Torasemide

Key facts

• Active Substance:
  • eplerenone
  • Torasemide
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0530/2022
• PIP number:
  EMEA-003289-PIP01-22
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of heart failure
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Win Medica S.A.

  E-mail: [e-mail]; Tel. [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  30/12/2022

Decision

P/0530/2022 : EMA decision of 30 December 2022 on the granting of a product specific waiver for torasemide / eplerenone (EMEA-003289-PIP01-22)

AdoptedReference Number: EMA/929797/2022