EMEA-002024-PIP01-16 - paediatric investigation plan

hydrochlorothiazide

Candesartan cilexetil

amlodipine besilate

Key facts

• Active substance:
  • hydrochlorothiazide
  • Candesartan cilexetil
  • amlodipine besilate
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0037/2017
• PIP number:
  EMEA-002024-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:
  31/01/2017
• Compliance check done:
  No

Decision

P/0037/2017: European Medicines Agency decision of 31 January 2017 on the granting of a product specific waiver for hydrochlorothiazide / amlodipine (besylate) / candesartan (cilexetil) (EMEA-002024-PIP01-16)

Adopted Reference Number: EMA/36030/2017