Medicinal product name BeneFIX
Pharmaceutical form Powder and solvent for solution for injection
Strength 1500 IU 
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 B02BD04 Antihemorrhagics

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
(1500 IU)
Glass vial, pre-filled syringe, injection set    EU/1/97/047/009  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/1/97/047/009
Date of authorisation Aug 27, 1997
Marketing authorisation holder, country Pfizer Europe MA EEIG, Belgium