EMEA-000823-PIP02-10 - paediatric investigation plan

Amlodipine besilate

perindopril tert-butylamine

Key facts

• Active Substance:
  • Amlodipine besilate
  • perindopril tert-butylamine
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/70/2011
• PIP number:
  EMEA-000823-PIP02-10
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  • Prevention of heart failure
  • Prevention of stroke
  • Treatment of acute myocardial infarction
  • Treatment of atherosclerotic heart disease
  • Treatment of heart failure
  • Treatment of Prinzmetal's angina
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Gedeon Richter Plc.

  [e-mail]; Hungary; Tel. [phone]; Fax. [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  04/04/2011

Decision

P/70/2011: EMA decision of 4 April 2011 on the granting of a product specific waiver for amlodipine besilate / perindopril tert-butylamine (EMEA-000823-PIP02-10)

AdoptedReference Number: EMA/212712/2011