EMEA-001607-PIP01-13 - paediatric investigation plan

amlodipine besilate

ramipril

Key facts

• Active substance:
  • amlodipine besilate
  • ramipril
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0154/2014
• PIP number:
  EMEA-001607-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:
  13/06/2014
• Compliance check done:
  No

Decision

P/0154/2014: EMA decision of 13 June 2014 on the granting of a product specific waiver for amlodipine besilate / ramipril (EMEA-001607-PIP01-13)

Adopted Reference Number: EMA/268742/2014