EMEA-002906-PIP01-20 - paediatric investigation plan

amlodipine

hydrochlorothiazide

ramipril

Key facts

• Active substance:
  • amlodipine
  • hydrochlorothiazide
  • ramipril
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0085/2021
• PIP number:
  EMEA-002906-PIP01-20
• 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:
  19/03/2021
• Compliance check done:
  No

Decision

P/0085/2021 : EMA decision of 19 March 2021 on the granting of a product specific waiver for hydrochlorothiazide / amlodipine / ramipril (EMEA- 002906-PIP01-20)

Adopted Reference Number: EMA/73040/2021