EMEA-001706-PIP01-14-M03 - paediatric investigation plan

Enalapril (maleate)

Key facts

• Active substance:
  Enalapril (maleate)
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0093/2021
• PIP number:
  EMEA-001706-PIP01-14-M03
• Pharmaceutical form(s):
  Age appropriate oral solid dosage form
• 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:
  17/03/2021
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001706-PIP01-14-M03
• Compliance opinion date:
  25/06/2021
• Compliance outcome:
  Positive

Decision

P/0093/2021: EMA decision of 17 March 2021 on the acceptance of a modification of an agreed paediatric investigation plan for enalapril (maleate) (EMEA-001706-PIP01-14-M03)

Adopted Reference Number: EMA/94579/2021