Olmesartan medoxomil / amlodipine besilate / hydrochlorothiazide - paediatric investigation plan

olmesartan medoxomil

amlodipine besilate

hydrochlorothiazide

Key facts

• Active substance:
  • olmesartan medoxomil
  • amlodipine besilate
  • hydrochlorothiazide
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/226/2009
• PIP number:
  Olmesartan medoxomil / amlodipine besilate / hydrochlorothiazide
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  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:
  04/11/2009
• Compliance check done:
  No

Decision

P/226/2009: European Medicines Agency Decision of 4 November 2009 on the granting of a product specific waiver for olmesartan medoxomil / amlodipine besilate / hydrochlorothiazide (EMEA-000666-PIP01-09) in accordance wit...

Adopted Reference Number: EMEA/693323/2009