P/0323/2014 - paediatric investigation plan

amlodipine

Ramipril

Key facts

• Active Substance:
  • amlodipine
  • Ramipril
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0323/2014
• PIP number:
  P/0323/2014
• 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:
  19/12/2014

Decision

P/0323/2014: EMA decision of 19 December 2014 on the granting of a product specific waiver for amlodipine / ramipril (EMEA-001685-PIP01-14)

AdoptedReference Number: EMA/755900/2014