Salmeteroli xinafoas, Fluticasoni propionas

Medicinal product name BroPair Spiromax
Pharmaceutical form Inhalation powder
Strength 12.75 μg/100 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 R03AK06 Drugs for obstructive airway diseases

Important notice

Additional information regarding the use for persons aged 75+

If used as "DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES"
SubstanceClassComment
Salmeteroli xinafoasASuitable for older persons. Potentiates sympathomimetic effects. May cause hypokalaemia.
Fluticasoni propionasASuitable for older persons. Take into account possible systemic adverse effects. Take interactions into account.

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 N1: 60 devas
(12,75 µg/100 µg)
ABS/PE/PP inhaler    EU/1/21/1534/001  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/1/21/1534/001
Date of authorisation Feb 26, 2021
Marketing authorisation holder, country Teva B.V., Netherlands