EMEA-003186-PIP01-22 - paediatric investigation plan

Indapamide

Perindopril (arginine)

Key facts

• Active Substance:
  • Indapamide
  • Perindopril (arginine)
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0212/2022
• PIP number:
  EMEA-003186-PIP01-22
• Pharmaceutical form(s):
  Capsule (hard)
• Condition(s) / indication(s):
  Treatment of hypertension
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Les Laboratoires Servier

  [e-mail]; [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  10/06/2022

Decision

P/0212/2022: EMA decision 10 June 2022 on the granting of a product specific waiver for perindopril (arginine) / indapamide (EMEA-003186- PIP01-22)

AdoptedReference Number: EMA/365818/2022