EMEA-001048-PIP01-10 - paediatric investigation plan

perindopril arginine

Indapamide

amlodipine besilate

Key facts

• Active substance:
  • perindopril arginine
  • Indapamide
  • amlodipine besilate
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/17/2011
• PIP number:
  EMEA-001048-PIP01-10
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of arterial 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:
  21/01/2011
• Compliance check done:
  No

Decision

P/17/2011: EMA decision of 21 January 2011 on the granting of a product specific waiver for perindopril arginine / indapamide / amlodipine besilate(EMEA-001048-PIP01-10) in accordance with Regulation (EC) No 1901/2006...

Adopted Reference Number: EMA/800809/2010