EMEA-003070-PIP01-21 - paediatric investigation plan

ramipril

amlodipine besilate

Key facts

• Active substance:
  • ramipril
  • amlodipine besilate
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0513/2021
• PIP number:
  EMEA-003070-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:
  03/12/2021
• Compliance check done:
  No

Decision

P/0513/2021 : EMA decision of 3 December 2021 on the granting of a product specific waiver for ramipril / amlodipine (besilate), (EMEA-003070-PIP01- 21)

Adopted Reference Number: EMA/624526/2021