Medicinal product name Amlodipine/Valsartan Mylan
Pharmaceutical form Film-coated tablet
Strength 5 mg/160 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 C09DB01 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 N14
(5 mg/160 mg)
PCTFE/PVC blister    EU/1/16/1092/014  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/1/16/1092/014
Date of authorisation Mar 22, 2016
Marketing authorisation holder, country Mylan Pharmaceuticals Limited, Ireland