EMA/PE/0000224486 - paediatric investigation plan

amlodipine

ramipril

rosuvastatin

Key facts

• Active substance:
  • amlodipine
  • ramipril
  • rosuvastatin
• Therapeutic area:
  Vascular disorders
• Decision number:
  EMA/PE/0000224486
• PIP number:
  EMA/PE/0000224486
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  • Treatment of coronary artery disease
  • Treatment of essential hypertension
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  05/12/2024
• Compliance check done:
  No

Decision

EMA/PE/0000224486: EMA decision of 5 December 2024 on the granting of a product specific waiver for amlodipine, ramipril, rosuvastatin

Adopted Reference Number: EMADOC-1700519818-1792333