Medicinal product name Nivestim
Biosimilar medicine
Pharmaceutical form Solution for injection/infusion
Strength 48 MU (480 µg/0.5 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 L03AA02 Immunostimulants

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
(480 µg/0,5 ml)
Glass pre-filled syringe    EU/1/10/631/009  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/1/10/631/009
Date of authorisation Jun 8, 2010
Marketing authorisation holder, country Pfizer Europe MA EEIG, Belgium