Medicinal product name Refixia
Pharmaceutical form Powder and solvent for solution for injection
Strength 500 IU 
Information from the MAH on shortages Not notified
Legal status Rx Prescription (Pr.II hem.)
 Summary of product characteristics, patient information leaflet and labeling text approved by the European Medicines Agency is available on European Medicines Agency website
Conclusion on the therapeutic and cost effectiveness of medicines Feb 10, 2021 D67
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
(500 IU/4 ml)
Glass vial, pre-filled syringe, transfer adapter    EU/1/17/1193/001  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/1/17/1193/001
Date of authorisation Jun 2, 2017
MA valid until For unlimited time
Marketing authorisation holder, country Novo Nordisk A/S, Denmark