EMEA-002104-PIP01-16 - paediatric investigation plan

olmesartan medoxomil

hydrochlorothiazide

amlodipine besilate

Key facts

• Active substance:
  • olmesartan medoxomil
  • hydrochlorothiazide
  • amlodipine besilate
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0177/2017
• PIP number:
  EMEA-002104-PIP01-16
• Pharmaceutical form(s):
  Tablet
• 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:
  03/07/2017
• Compliance check done:
  No

Decision

P/0177/2017: EMA decision of 3 July 2017 on the granting of a product specific waiver for olmesartan medoxomil/amlodipine (besilate)/hydrochlorothiazide (EMEA-002104-PIP01-16)

Adopted Reference Number: EMA/382336/2017