EMEA-001711-PIP01-14 - paediatric investigation plan

Candesartan

amlodipine

Key facts

• Active substance:
  • Candesartan
  • amlodipine
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0051/2015
• PIP number:
  EMEA-001711-PIP01-14
• Pharmaceutical form(s):
  • Capsule, hard
  • 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:
  06/03/2015
• Compliance check done:
  No

Decision

P/0051/2015: EMA decision of 6 March 2015 on the granting of a product-specific waiver for candesartan / amlodipine (EMEA-001711-PIP01-14)

Adopted Reference Number: EMA/49322/2015