EMEA-001871-PIP01-15 - paediatric investigation plan

ramipril

amlodipine

Key facts

• Active substance:
  • ramipril
  • amlodipine
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0048/2016
• PIP number:
  EMEA-001871-PIP01-15
• 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:
  04/02/2016
• Compliance check done:
  No

Decision

P/0048/2016: EMA decision of 4 March 2016 on the granting of a product specific waiver for ramipril / amlodipine (EMEA-001871-PIP01-15)

Adopted Reference Number: EMA/90061/2016