Medicinal product name LIBTAYO
Pharmaceutical form Concentrate for solution for infusion
Strength 350 mg 
Information from the MAH on shortages No information on expected shortages
Legal status Rx Prescription (Pr.II onk. ķīm. ter.)
KZS NHS Reimbursed medicines
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 pacientam Izglītojošie materiāli pacientam
Conclusion on the therapeutic and cost effectiveness of medicines Dec 7, 2020 C44
ATC code L01FF06 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 N1
(350 mg/7 ml)
Glass vial 8610.80 
KZS*
EU/1/19/1376/001  Summary of product characteristics, patient information leaflet and labeling text approved by the European Medicines Agency is available on European Medicines Agency website
* Indication about medicine on the List of state reimbursed medicines is just informative. Source of the information is the National Health Service. For details please visit the NHS website.

Registration information

Marketing authorisation No. EU/1/19/1376/001
Date of authorisation Jun 28, 2019
Marketing authorisation holder, country Regeneron Ireland U.C., Ireland