EMEA-001294-PIP01-12 - paediatric investigation plan

azilsartan medoxomil

chlortalidone

Key facts

• Active substance:
  • azilsartan medoxomil
  • chlortalidone
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0224/2012
• PIP number:
  EMEA-001294-PIP01-12
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of hypertension
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  01/10/2012
• Compliance check done:
  No

Decision

P/0224/2012: EMA decision of 1 October 2012 on the granting of a product specific waiver for azilsartan medoxomil / chlortalidone (EMEA-001294- PIP01-12)

Adopted Reference Number: EMA/568807/2012