EMEA-001447-PIP02-21 - paediatric investigation plan

ezetimibe

rosuvastatin

Key facts

• Active substance:
  • ezetimibe
  • rosuvastatin
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0411/2021
• PIP number:
  EMEA-001447-PIP02-21
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Prevention of cardiovascular disease
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  29/10/2021
• Compliance check done:
  No

Decision

P/0411/2021 : EMA decision of 29 October 2021 on the granting of a product specific waiver for rosuvastatin / ezetimibe (Rosuvastatin/ezetimibe EGIS and associated names), (EMEA-001447-PIP02-21)

Adopted Reference Number: EMA/535334/2021