EMEA-001578-PIP01-13 - paediatric investigation plan

amlodipine

rosuvastatin

Key facts

• Active substance:
  • amlodipine
  • rosuvastatin
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0121/2014
• PIP number:
  EMEA-001578-PIP01-13
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  • Prevention of cardiovascular events
  • Treatment of ischemic coronary artery disorders
  • Treatment of hypertension
  • Treatment of 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:
  07/05/2014
• Compliance check done:
  No

Decision

P/0121/2014: EMA decision of 7 May 2014 on the granting of a product specific waiver for amlodipine / rosuvastatin (EMEA-001578-PIP01-13)

Adopted Reference Number: EMA/195552/2014