EMEA-001478-PIP01-13 - paediatric investigation plan

Ezetimibe

Rosuvastatin

Key facts

• Active Substance:
  • Ezetimibe
  • Rosuvastatin
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0274/2013
• PIP number:
  EMEA-001478-PIP01-13
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of elevated cholesterol
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  30/10/2013

Decision

P/0274/2013: EMA decision of 30 October 2013 on the granting of a product specific waiver for ezetimibe / rosuvastatin (EMEA-001478-PIP01-13)

Reference Number: EMA/587702/2013