EMEA-002174-PIP01-17 - paediatric investigation plan

hydrochlorothiazide

Candesartan cilexetil

amlodipine besilate

Key facts

• Active substance:
  • hydrochlorothiazide
  • Candesartan cilexetil
  • amlodipine besilate
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0291/2017
• PIP number:
  EMEA-002174-PIP01-17
• 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:
  04/10/2017
• Compliance check done:
  No

Decision

P/0291/2017: EMA decision of 4 October 2017 on the granting of a product specific waiver for amlodipine (besylate) / candesartan (cilexetil) / hydrochlorothiazide (EMEA-002174-PIP01-17)

Adopted Reference Number: EMA/574573/2017