EMEA-003151-PIP01-21 - paediatric investigation plan

Indapamide

Telmisartan

Key facts

• Active Substance:
  • Indapamide
  • Telmisartan
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0111/2022
• PIP number:
  EMEA-003151-PIP01-21
• Pharmaceutical form(s):
  Modified-release tablet
• 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:
  13/04/2022

Decision

P/0111/2022 : EMA decision of 13 April 2022 on the granting of a product-specific waiver for telmisartan / indapamide (EMEA-003151-PIP01-21)

AdoptedReference Number: EMA/145596/2022