EMEA-003466-PIP01-23 - paediatric investigation plan

amlodipine

atorvastatin

Candesartan

Key facts

• Active substance:
  • amlodipine
  • atorvastatin
  • Candesartan
• Therapeutic area:
  Cardiac disorders
• Decision number:
  P/0465/2023
• PIP number:
  EMEA-003466-PIP01-23
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Prevention of cardiovascular events
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  01/12/2023
• Compliance check done:
  No

Decision

P/0465/2023 : EMA decision of 1 December 2023 on the granting of a product-specific waiver for amlodipine / atorvastatin / candesartan (EMEA-003466-PIP01-23)

Adopted Reference Number: EMA/526338/2023