EMEA-002135-PIP01-17 - paediatric investigation plan

ezetimibe

rosuvastatin calcium

Key facts

• Active substance:
  • ezetimibe
  • rosuvastatin calcium
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0185/2017
• PIP number:
  EMEA-002135-PIP01-17
• 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:
  30/06/2017
• Compliance check done:
  No

Decision

P/0185/2017: EMA decision of 30 June 2017 on the granting of a product-specific waiver for rosuvastatin (calcium) / ezetimibe (EMEA-002135- PIP01-17)

Adopted Reference Number: EMA/371180/2017