Medicinal product name Bemfola
Biosimilar medicine
Pharmaceutical form Solution for injection
Strength 225 IU/0.375 ml 
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 G03GA05 Sex hormones and modulators of the genital 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 N10
(225 IU/0,375 ml)
Glass cartridge in pre-filled pen    EU/1/13/909/011  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/1/13/909/011
Date of authorisation Mar 27, 2014
Marketing authorisation holder, country Gedeon Richter Plc., Hungary