EMEA-001471-PIP01-13 - paediatric investigation plan

ramipril

amlodipine besilate

Key facts

• Active substance:
  • ramipril
  • amlodipine besilate
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0241/2013
• PIP number:
  EMEA-001471-PIP01-13
• 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:
  24/09/2013
• Compliance check done:
  No

Decision

P/0241/2013: EMA decision of 24 September 2013 on the granting of a product specific waiver for ramipril / amlodipine (besilate) (EMEA-001471-PIP01-13)

Adopted Reference Number: EMA/496894/2013