EMEA-002395-PIP01-18 - paediatric investigation plan

atorvastatin (calcium trihydrate)

Indapamide

perindopril arginine

Key facts

• Active Substance:
  • atorvastatin (calcium trihydrate)
  • Indapamide
  • perindopril arginine
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0333/2018
• PIP number:
  EMEA-002395-PIP01-18
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of cardiovascular disease
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  08/10/2018

Decision

P/0333/2018: EMA decision of 8 October 2018 on the granting of a product-specific waiver for atorvastatin (calcium trihydrate) / perindopril (arginine) / indapamide (EMEA-002395-PIP01-18)

AdoptedReference Number: EMA/651668/2018