EMEA-001278-PIP01-12 - paediatric investigation plan

rosuvastatin

ezetimibe

Key facts

• Active substance:
  • rosuvastatin
  • ezetimibe
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0181/2012
• PIP number:
  EMEA-001278-PIP01-12
• Pharmaceutical form(s):
  • Film-coated tablet
  • Tablet
• Condition(s) / indication(s):
  Treatment of hypercholesterolaemia
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  20/08/2012
• Compliance check done:
  No

Decision

P/0181/2012: EMA decision of 20 August 2012 on the granting of a product specific waiver for rosuvastatin / ezetimibe (EMEA-001278-PIP01-12)

Adopted Reference Number: EMA/480335/2012