EMEA-001377-PIP01-12 - paediatric investigation plan

valsartan

Indapamide

Key facts

• Active substance:
  • valsartan
  • Indapamide
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0039/2013
• PIP number:
  EMEA-001377-PIP01-12
• Pharmaceutical form(s):
  • Film-coated tablet
  • Prolonged-release tablet
• Condition(s) / indication(s):
  • Treatment of heart failure
  • Treatment of acute myocardial infarction
  • Treatment of essential 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:
  27/02/2013
• Compliance check done:
  No

Decision

P/0039/2013: EMA decision of 27 February 2013 on the granting of a product-specific waiver for valsartan / indapamide (EMEA-001377-PIP01-12)

Adopted Reference Number: EMA/23964/2013