EMEA-002794-PIP01-20 - paediatric investigation plan

ramipril

Bisoprolol fumarate

Key facts

• Active substance:
  • ramipril
  • Bisoprolol fumarate
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0390/2020
• PIP number:
  EMEA-002794-PIP01-20
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  • Treatment of coronary artery disease
  • Treatment of heart failure
  • 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:
  16/10/2020
• Compliance check done:
  No

Decision

P/0390/2020 : EMA decision of 16 October 2020 on the granting of a product specific waiver for ramipril / bisoprolol (fumarate) (EMEA-002794-PIP01-20)

Adopted Reference Number: EMA/415325/2020