EMEA-003412-PIP01-23 - paediatric investigation plan

amlodipine besilate

rivaroxaban

Key facts

• Active substance:
  • amlodipine besilate
  • rivaroxaban
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0244/2023
• PIP number:
  EMEA-003412-PIP01-23
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  • Prevention of thromboembolic events
  • Treatment of 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:
  14/07/2023
• Compliance check done:
  No

Decision

P/0244/2023 : EMA decision of 14 July 2023 on the granting of a product specific waiver for amlodipine (besilate) / rivaroxaban (EMEA-003412- PIP01-23)

Reference Number: EMA/300031/2023