EMEA-002005-PIP01-16 - paediatric investigation plan

amlodipine

atorvastatin

Key facts

• Active substance:
  • amlodipine
  • atorvastatin
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0306/2016
• PIP number:
  EMEA-002005-PIP01-16
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  • Treatment of concomitant hypertension and dyslipidaemia
  • Treatment of concomitant angina and dyslipidaemia
  • Prevention of cardiovascular events in hypertension and diabetes mellitus type II
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  04/11/2016
• Compliance check done:
  No

Decision

P/0306/2016: EMA decision of 4 November 2016 on the granting of a product specific waiver for amlodipine / atorvastatin (EMEA-002005-PIP01-16)

Adopted Reference Number: EMA/669062/2016