EMEA-002560-PIP01-19 - paediatric investigation plan

Bisoprolol fumarate

ramipril

Key facts

• Active substance:
  • Bisoprolol fumarate
  • ramipril
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0254/2019
• PIP number:
  EMEA-002560-PIP01-19
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  • 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:
  17/07/2019
• Compliance check done:
  No

Decision

P/0254/2019: EMA decision of 17 July 2019 on the granting of a product specific waiver for bisoprolol fumarate / ramipril, (EMEA-002560-PIP01-19)

Adopted Reference Number: EMA/364987/2019