EMEA-002531-PIP01-18 - paediatric investigation plan

Ramipril

bisoprolol

Key facts

• Active Substance:
  • Ramipril
  • bisoprolol
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0212/2019
• PIP number:
  EMEA-002531-PIP01-18
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  • Treatment of coronary artery disease
  • Treatment of heart failure
  • Treatment of hypertension
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Midas Pharma GmbH

  E-mail: [e-mail]; Tel. [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  12/06/2019

Decision

P/0212/2019: EMA decision of 13 June 2019 on the granting of a product specific waiver for ramipril / bisoprolol (EMEA-002531-PIP01-18)

AdoptedReference Number: EMA/275981/2019