EMEA-003372-PIP01-22 - paediatric investigation plan

ramipril

Indapamide

Key facts

• Active substance:
  • ramipril
  • Indapamide
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0157/2023
• PIP number:
  EMEA-003372-PIP01-22
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  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:
  12/05/2023
• Compliance check done:
  Όχι

Decision

P/0157/2023: EMA decision of 12 May 2023 on the granting of a product-specific waiver for ramipril / indapamide (EMEA-003372-PIP01-22)

Reference Number: EMA/170257/2023