EMEA-002257-PIP02-19 - paediatric investigation plan

rosuvastatin

ezetimibe

Key facts

• Invented name:
  • Rosuvastatin and associated names
  • Ezetimibe Elpen and associated names
• Active substance:
  • rosuvastatin
  • ezetimibe
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0079/2020
• PIP number:
  EMEA-002257-PIP02-19
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Prevention of cardiovascular events
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  18/03/2020
• Compliance check done:
  No

Decision

P/0079/2020: EMA decision of 18 March 2020 on the granting of a product specific waiver for rosuvastatin / ezetimibe (Rosuvastatin/Ezetimibe Elpen and associated names), (EMEA-002257-PIP02-19)

Adopted Reference Number: EMA/114310/2020