EMEA-003498-PIP01-23 - paediatric investigation plan

Ramipril

Indapamide

Key facts

• Active Substance:
  • Ramipril
  • Indapamide
• Therapeutic area:
  Vascular disorders
• Decision number:
  P/0466/2023
• PIP number:
  EMEA-003498-PIP01-23
• 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:
  01/12/2023

Decision

P/0466/2023 : EMA decision of 1 December 2023 on the granting of a product-specific waiver for ramipril / indapamide (EMEA-003498-PIP01-23)

AdoptedReference Number: EMA/501922/2008