Candesartan cilexetil - paediatric investigation plan

Candesartan cilexetil

Key facts

• Invented name:
  Atacand and associated name
• Active substance:
  Candesartan cilexetil
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/21/2009
• PIP number:
  Candesartan cilexetil
• Pharmaceutical form(s):
  • Tablet
  • Suspension for oral use
• Condition(s) / indication(s):
  • Diabetic retinopathy
  • Essential hypertension
  • Heart Failure
• Route(s) of administration:
  Oral use
• Decision type:
  RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
• Decision date:
  20/02/2009
• Compliance check done:
  No

Decision

P/21/2009: European Medicines Agency decision of 23 February 2009 on the refusal of a Paediatric Investigation Plan and on the refusal of a waiver for candesartan cilexetil (Atacand and associated name), (EMEA-000021-PIP...

Adopted Reference Number: EMEA/95694/2009