EMEA-002024-PIP02-22 - paediatric investigation plan

candesartan (cilexetil)

amlodipine

hydrochlorothiazide

Key facts

• Active Substance:
  • candesartan (cilexetil)
  • amlodipine
  • hydrochlorothiazide
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0059/2023
• PIP number:
  EMEA-002024-PIP02-22
• Pharmaceutical form(s):
  Capsule (hard)
• Condition(s) / indication(s):
  Treatment of hypertension
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Adamed Pharma S.A.

  E-mail: [e-mail]; Tel: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  21/02/2023

Decision

P/0059/2023 : EMA decision of 21 February 2023 on the granting of a product specific waiver for candesartan (cilexetil) / amlodipine / hydrochlorothiazide (EMEA-002024-PIP02-22)

Reference Number: EMA/25295/2023