EMEA-001771-PIP01-15 - paediatric investigation plan

Indapamide

Rosuvastatin

perindopril tert-butylamine

Key facts

• Active Substance:
  • Indapamide
  • Rosuvastatin
  • perindopril tert-butylamine
• Therapeutic area:
  • Cardiovascular diseases
  • Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0201/2015
• PIP number:
  EMEA-001771-PIP01-15
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  • Prevention of cardiovascular events
  • Treatment of hypertension
  • Treatment of lipid metabolism disorders
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  04/09/2015

Decision

P/0201/2015: EMA decision of 4 September 2015 on the granting of a product specific waiver for indapamide / perindopril (tert-butylamine) / rosuvastatin (EMEA-001771-PIP01-15)

AdoptedReference Number: EMA/568913/2015