EMEA-000823-PIP01-10 - paediatric investigation plan

Amlodipine besilate

perindopril tert-butylamine

Key facts

• Active Substance:
  • Amlodipine besilate
  • perindopril tert-butylamine
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/134/2010
• PIP number:
  EMEA-000823-PIP01-10
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of hypertension
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Gedeon Richter Plc.

  E-mail: [e-mail]; Country: Hungary; Phone: [phone]; Fax: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  28/07/2010

Decision

P/134/2010: European Medicines Agency decision of 28 July 2010 on the granting of a product specific waiver for amlodipine besilate/perindopril tert-butylamine (EMEA-000823-PIP01-10) in accordance with Regulation (EC) N...

AdoptedReference Number: EMA/465065/2010