Medicinal product name Darzalex
Pharmaceutical form Solution for injection
Strength 1800 mg 
Information from the MAH on shortages No information on expected shortages
Availability of medicinal product
Product No.Package sizeWholesalers' stock state
EU/1/16/1101/004 KZSN1 Is available
Legal status Rx Prescription (Pr.II anest.)
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 ārstam Izglītojošie materiāli ārstam
Izglītojošie materiāli pacientam Izglītojošie materiāli pacientam
Conclusion on the therapeutic and cost effectiveness of medicines Apr 21, 2022 E85.8
 Nov 11, 2022 C90.0
ATC code L01FC01 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)
(14 containers)
Tamro N1
(1800 mg/15 ml)
Glass vial 8102.98 
KZS*
EU/1/16/1101/004  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/1/16/1101/004
Date of authorisation May 20, 2016
Marketing authorisation holder, country Janssen-Cilag International NV, Belgium