Amlodipinum, Valsartanum, Hydrochlorothiazidum

Medicinal product name Dafiro HCT
Pharmaceutical form Film-coated tablet
Strength 5 mg/160 mg/12.5 mg 
Information from the MAH on shortages Not notified
Legal status Rx Prescription (Pr.)
Summary of product characteristics, package leaflet and labeling text  Summary of product characteristics, patient information leaflet and labeling text approved by the European Medicines Agency is available on European Medicines Agency website
ATC code C09DX01 Agents acting on the renin-angiotensin system

Medicinal products (1)

Availability of medicinal product Wholesalers Package size, content Primary packaging Maximum admissible pharmacy price (€ incl. VAT) Product No. Labelling
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N90
(1 UD)
PVC/PVDC blister    EU/1/09/574/005  Summary of product characteristics, patient information leaflet and labeling text approved by the European Medicines Agency is available on European Medicines Agency website

Registration information

Marketing authorisation No. EU/1/09/574/005
Date of authorisation Nov 4, 2009
Marketing authorisation holder, country Novartis Europharm Limited, Ireland