EMEA-002569-PIP04-19 - paediatric investigation plan

rosuvastatin

ramipril

Key facts

• Active substance:
  • rosuvastatin
  • ramipril
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0343/2019
• PIP number:
  EMEA-002569-PIP04-19
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  • Prevention of cardiovascular events
  • Treatment of hypertension
  • Treatment of lipid metabolism disorders
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  11/09/2020
• Compliance check done:
  No

Decision

P/0343/2019: EMA decision of 11 September 2019 on the granting of a product specific waiver for rosuvastatin / ramipril (EMEA-002569-PIP01-19)

Adopted Reference Number: EMA/466404/2019