EMEA-002520-PIP01-18 - paediatric investigation plan

Candesartan

atorvastatin

amlodipine

Key facts

• Active substance:
  • Candesartan
  • atorvastatin
  • amlodipine
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0187/2019
• PIP number:
  EMEA-002520-PIP01-18
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  • Treatment of hypercholesterolaemia
  • 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:
  15/05/2019
• Compliance check done:
  No

Decision

P/0187/2019: EMA decision of 15 May 2019 on the granting of a product specific waiver for candesartan / atorvastatin / amlodipine (EMEA-002520-PIP01-18)

Adopted Reference Number: EMA/216790/2019