EMEA-002849-PIP01-20 - paediatric investigation plan

Amlodipine besilate

Indapamide

perindopril arginine

Key facts

• Active Substance:
  • Amlodipine besilate
  • Indapamide
  • perindopril arginine
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0470/2020
• PIP number:
  EMEA-002849-PIP01-20
• Pharmaceutical form(s):
  Tablet
• 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:
  04/12/2020

Decision

P/0470/2020 : EMA decision of 4 December 2020 on the granting of a product specific waiver for amlodipine (besilate)/ indapamide/ perindopril (arginine) (EMEA-002849-PIP01-20)

AdoptedReference Number: EMA/622826/2020