EMEA-001344-PIP02-17 - paediatric investigation plan

ezetimibe

rosuvastatin

Key facts

• Invented name:
  • Zenon
  • Suvezen
• Active substance:
  • ezetimibe
  • rosuvastatin
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0126/2018
• PIP number:
  EMEA-001344-PIP02-17
• Pharmaceutical form(s):
  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:
  11/04/2018
• Compliance check done:
  No

Decision

P/0126/2018: EMA decision of 11 April 2018 on the granting of a product specific waiver for ezetimibe / rosuvastatin (Zenon, Suvezen), (EMEA-001344-PIP02-17)

Reference Number: EMA/152181/2018