EMEA-003530-PIP01-23 - paediatric investigation plan

nebivolol

ramipril

Key facts

• Active Substance:
  • nebivolol
  • ramipril
• Therapeutic area:
  Cardiac disorders
• Decision number:
  P/0106/2024
• PIP number:
  EMEA-003530-PIP01-23
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  • Treatment of coronary artery disease
  • Treatment of heart failure
  • Treatment of hypertension
  • Treatment of hypertension with coexisting coronary artery disease
  • Treatment of hypertension with coexisting heart failure
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  12/04/2024

Decision

P/0106/2024: EMA decision of 12 April 2024 on the granting of a product specific waiver for nebivolol / ramipril (EMEA-003530-PIP01-23)

AdoptedReference Number: EMA/99223/2024