Medicinal product name Ruxience
Biosimilar medicine
Pharmaceutical form Concentrate for solution for infusion
Strength 500 mg 
Information from the MAH on shortages No information on expected shortages
Availability of medicinal product
Product No.Package sizeWholesalers' stock state
EU/1/20/1431/002N1 Is available
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
Risk minimisation measuresIzglītojošie materiāli ārstam Izglītojošie materiāli ārstam
Izglītojošie materiāli pacientam Izglītojošie materiāli pacientam
Izglītojošie materiāli pacientam Izglītojošie materiāli pacientam
ATC code L01FA01 Antineoplastic agents

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)
(294 containers)
Recipe Plus N1
(500 mg/50 ml)
Glass vial 1901.58  EU/1/20/1431/002  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/1/20/1431/002
Date of authorisation Apr 1, 2020
Marketing authorisation holder, country Pfizer Europe MA EEIG, Belgium