Medicinal product name Spectrila
Pharmaceutical form Powder for concentrate for solution for infusion
Strength 10 000 U 
Information from the MAH on shortages Not notified
Legal status Rx Prescription (Pr.II onk. ķīm. ter.)
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 L01XX02 Antineoplastic agents

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 N5
(10000 U)
Glass vial    EU/1/15/1072/002  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/1/15/1072/002
Date of authorisation Jan 14, 2016
Marketing authorisation holder, country Medac Gesellschaft für klinische Spezialpräparate mbH, Germany