EMEA-000008-PIP01-07 - paediatric investigation plan

Losartan potassium

Key facts

• Active substance:
  Losartan potassium
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/9/2008
• PIP number:
  EMEA-000008-PIP01-07
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate oral liquid dosage formulation
• Condition(s) / indication(s):
  • Proteinuria
  • Treatment of heart failure
  • Treatment of hypertension
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  29/02/2008
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000008-PIP01-07
• Compliance opinion date:
  06/02/2009
• Compliance outcome:
  Positive

Decision

P/9/2008: European medicines agency decision of 29 February 2008 on the application for agreement of a Paediatric Investigation Plan for Cozaar and associated names, losartan potassium EMEA-000008-PIP01-07 in accordance ...

Adopted Reference Number: EMEA/96630/2008