Medicinal product name Febuxostat Mylan
Pharmaceutical form Film-coated tablet
Strength 120 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 M04AA03 Antigout preparations

Important notice

Additional information regarding the use for persons aged 75+

If used as "ANTIGOUT PREPARATIONS"
SubstanceClassComment
FebuxostatumCSuitable for older adults, with specific precautions. Do not use on patients with severe arterial disease.

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 N28
(120 mg)
HDPE bottle    EU/1/17/1194/015  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/1/17/1194/015
Date of authorisation Jun 15, 2017
Marketing authorisation holder, country Mylan Pharmaceuticals Limited, Ireland