Antineoplastic And Immunomodulating Agans - Medicinal Product For Autologous Cell Therapy - Idekabtagen Vikleucece - 2025. Cytostatic For Car-T Therapy (Idekabtagen Vikleucel)-Infusion Bag Containing Cellular Dispersion 260-500 X 10⁶ Car-Positive Viable T-Lymphocytes. The Expected Annual Volume Is 8 Doses, Each Corresponding To The Amount Of Drug Administered To One Patient According To Their Individual Needs (One Or More Infusion Bags), Atc L01xl07. The Dose Means An Individually Determined Amount Of Drug That Corresponds To A One -Off Application To A Particular Patient Based On Its Current Need, Regardless Of The Number Of Form Units. The Offered Medicinal Product Must Meet The Sukl Requirements. Sukl Registration Is A Necessary Condition For The Standard Use Of Medicinal Products Within The Provision Of Health Care Pursuant To Section 8 (1) Of Act No. 378/2007 Coll. The Fulfillment Of This Condition Is Evidenced By The Participant By Indicating The Valid Súkl Code Of The Offered Medicinal Product In The Relevant Column Of The Table To Supplement The Offer Prices, Which Contains Annex 1 Of The Tender Documentation (See Section 9.2.). The Medicinal Product Is Indicated For The Treatment Of Adult Patients With A Relaxing And Refractory Multiple Myeloma, Who Underwent At Least Two Previous Treatments Including An Immunomodulator, A Proteazoma Inhibitor And Anti-Cd38 Antibody And Have Manifested Disease Progression. Given That The Production Of Medicinal Products For Autologous Immunocellular Therapy Includes Highly Demanding And Specific Procedures And Is Subject To The Collection Of Biological Material Of Patients, The Contracting Authority Enables The Conclusion Of A Separate Contract/Separate Contracts, Regulating Detailed Conditions Of Cooperation And Defining The Responsibility Of Individual Professional Workplaces With The Product, Ensuring The Quality Of The Product, Processes, Qualifications And Certification, Etc.). However, The Content Of Any Of These Contracts Must Not Be Contrary To The Terms Of This Tender Documentation Incl. The Terms Of The Purchase Contract.
We takes all possible care for accurate & authentic tender information, however Users are requested to refer Original source of Tender Notice / Tender Document published by Tender Issuing Agency before taking any call regarding this tender.
