Budesonidum, Formoteroli fumaras dihydricus

Medicinal product name Budesonide/Formoterol Teva Pharma B.V.
Pharmaceutical form Inhalation powder
Strength 160 μg/4.5 μg 
Information from the MAH on shortages Not notified
Legal status Rx Prescription (Pr.)
 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 R03AK07 Drugs for obstructive airway diseases

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 N3: 3 × 120 devas
(160 µg/4,5 µg)
Inhaler    EU/1/19/1403/003  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/1/19/1403/003
Date of authorisation Apr 3, 2020
MA valid until For unlimited time
Marketing authorisation holder, country Teva Pharma B.V., Netherlands