Candesartan/Hydrochlorothiazide - paediatric investigation plan

Candesartan

hydrochlorothiazide

Key facts

• Invented name:
  Atacand Plus and associated names
• Active Substance:
  • Candesartan
  • hydrochlorothiazide
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/3/2007
• PIP number:
  Candesartan/Hydrochlorothiazide
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Cutaneous T-cell lymphoma (including ICD-10 codes C84.0 (mycosis fungoides) and C84.1 (Sezary's Disease)
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  11/12/2007

Decision

P/3/2007: European medicines agency decision of 11 December 2007 on the application for a product specific waiver for Atacand Plus and associated names, Candesartan/Hydrochlorothiazide (EMEA-000030-PIP01-07) in accordanc...

AdoptedReference Number: EMEA/575732/2007