EMEA-003285-PIP01-22 - paediatric investigation plan

Indapamide

valsartan

Key facts

• Active Substance:
  • Indapamide
  • valsartan
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0547/2022
• PIP number:
  EMEA-003285-PIP01-22
• Pharmaceutical form(s):
  Modified-release tablet
• Condition(s) / indication(s):
  Treatment of hypertension
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  KRKA, d.d., Novo mesto

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  30/12/2022

Decision

P/0547/2022 : EMA decision of 30 December 2022 on the granting of a product specific waiver for valsartan / indapamide (EMEA-003285-PIP01-22)

AdoptedReference Number: EMA/934658/2022