EMEA-001447-PIP01-12 - paediatric investigation plan

Rosuvastatin

Ezetimibe

Key facts

• Active Substance:
  • Rosuvastatin
  • Ezetimibe
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0131/2013
• PIP number:
  EMEA-001447-PIP01-12
• Pharmaceutical form(s):
  Capsule, hard
• 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:
  28/05/2013

Decision

P/0131/2013: EMA decision of 28 May 2013 on the granting of a product-specific waiver for rosuvastatin / ezetimibe (EMEA-001447-PIP01-12)

AdoptedReference Number: EMA/249740/2013