EMEA-001560-PIP01-13 - paediatric investigation plan

ramipril

amlodipine besilate

Key facts

• Invented name:
  BR/AM
• Active substance:
  • ramipril
  • amlodipine besilate
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0066/2014
• PIP number:
  EMEA-001560-PIP01-13
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of essential 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:
  10/03/2014
• Compliance check done:
  No

Decision

P/0066/2014: European Medicines Agency decision of 10 March 2014 on the granting of a product specific waiver for amlodipine (besylate) / ramipril (EMEA-001560-PIP01-13)

Adopted Reference Number: EMA/55126/2014