EMEA-003446-PIP01-23 - paediatric investigation plan

amlodipine

rosuvastatin

Key facts

• Active substance:
  • amlodipine
  • rosuvastatin
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0436/2023
• PIP number:
  EMEA-003446-PIP01-23
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  • Prevention of cardiovascular events
  • Treatment of hypertension
  • Treatment of ischemic cornary artery 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:
  27/10/2023
• Compliance check done:
  No

Decision

P/0436/2023 : EMA decision of 27 October 2023 on the granting of a product specific waiver for amlodipine / rosuvastatin (EMEA-003446-PIP01-23)

Adopted Reference Number: EMA/401517/2023