EMEA-000398-PIP01-08 - paediatric investigation plan

valsartan

hydrochlorothiazide

Amlodipine besilate

Key facts

• Invented name:
  • Dafiro HCT
  • Dafiro HCT
• Active Substance:
  • valsartan
  • hydrochlorothiazide
  • Amlodipine besilate
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/15/2009
• PIP number:
  EMEA-000398-PIP01-08
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Essential 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:
  27/01/2009

Decision

P/15/2009: European Medicines Agency decision of 27 January 2009 on the granting of a product specific waiver for amlodipine besylate, valsartan, hydrochlorothiazide, (Dafiro HCT), (EMEA-000398-PIP01-08) in accordance wi...

AdoptedReference Number: EMEA/24169/2009