EMEA-001085-PIP01-10 - paediatric investigation plan

atorvastatin calcium

amlodipine besilate

Key facts

• Active substance:
  • atorvastatin calcium
  • amlodipine besilate
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/94/2011
• PIP number:
  EMEA-001085-PIP01-10
• 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 dyslipidemia
  • Treatment of concomitant hypertension and dyslipidemia
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  04/04/2011
• Compliance check done:
  No

Decision

P/94/2011: EMA decision of 4 April 2011 on the granting of a product specific waiver for amlodipine (besylate) / atorvastatin (calcium) (EMEA- 001085-PIP01-10)

Adopted Reference Number: EMA/244984/2011