Medicinal product name Bemfola
Biosimilar medicine
Pharmaceutical form Solution for injection
Strength 300 IU/0.50 ml 
Information from the MAH on shortages No information on expected shortages
Availability of medicinal product
Product No.Package sizeWholesalers' stock state
EU/1/13/909/004 KZSRN1 Is available
Legal status Rx Prescription (Pr.)
KZSR Reimbursed medicines reference product
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
 Is available (according to the information provided by wholesalers)
(220 containers)
Recipe Plus, Saules aptieka, Tamro, Magnum Medical N1
(300 IU/0,5 ml)
Glass cartridge in pre-filled pen 91.03 
KZSR*
EU/1/13/909/004  Summary of product characteristics, patient information leaflet and labeling text approved by the European Medicines Agency is available on European Medicines Agency website
* Indication about medicine on the List of state reimbursed medicines is just informative. Source of the information is the National Health Service. For details please visit the NHS website.

Registration information

Marketing authorisation No. EU/1/13/909/004
Date of authorisation Mar 27, 2014
Marketing authorisation holder, country Gedeon Richter Plc., Hungary