EMEA-000362-PIP01-08-M04 - paediatric investigation plan

aliskiren

Key facts

• Invented name:
  • Rasilez
  • Rasilez
• Active substance:
  aliskiren
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0227/2014
• PIP number:
  EMEA-000362-PIP01-08-M04
• Pharmaceutical form(s):
  • Film-coated tablet
  • Granules
• Condition(s) / indication(s):
  • Heart Failure
  • Treatment of hypertension
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  06/09/2014
• Compliance check done:
  Non

Decision

P/0227/2014: EMA decision of 5 September 2014 on the acceptance of a modification of an agreed paediatric investigation plan for aliskiren (Rasilez and associated names), (EMEA-000362-PIP01-08-M04)

Adopted Reference Number: EMA/501292/2014