EMEA-003173-PIP01-21 - paediatric investigation plan

amlodipine

atorvastatin

Indapamide

perindopril arginine

Key facts

• Active substance:
  • amlodipine
  • atorvastatin
  • Indapamide
  • perindopril arginine
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0152/2022
• PIP number:
  EMEA-003173-PIP01-21
• Pharmaceutical form(s):
  Capsule, hard
• 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:
  20/05/2022
• Compliance check done:
  No

Decision

P/0152/2022 : EMA decision of 20 May 2022 on the granting of a product specific waiver for atorvastatin / perindopril (arginine) / indapamide / amlodipine (EMEA-003173-PIP01-21)

Adopted Reference Number: EMA/205787/2022