EMEA-001364-PIP01-12 - paediatric investigation plan

atorvastatin calcium

amlodipine besilate

Key facts

• Active substance:
  • atorvastatin calcium
  • amlodipine besilate
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0034/2013
• PIP number:
  EMEA-001364-PIP01-12
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  • Prevention of cardiovascular events in hypertensive patients and diabetes mellitus type II patients with multiple risk factors for cardiovascular disease
  • Treatment of concomitant angina and dyslipidaemia
  • Treatment of concomitant hypertension and dyslipidaemia
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  26/02/2013
• Compliance check done:
  No

Decision

P/0034/2013: EMA decision of 26 February 2013 on the granting of a product-specific waiver for amlodipine (besylate) / atorvastatin (calcium), (EMEA-001364-PIP01-12)

Adopted Reference Number: EMA/23839/2013