Antineoplastic And Immunomodulating Agans - Medicinal Product For Autologous Cell Therapy - Lisokabtagen Maraleucel - 2025. Cytostatic For Car-T Therapy (Lisokabtagen Maraleucel)-Injection Bottle Containing Cellular Dispersion 5.1-322 X 10⁶ Car-Positive Cd8+ T-Lymphocytes / Injection Bottle Containing Cellular Dispersion 5.1-322 X 10⁶ Car-Positive Cd4+ T-Lymphocytes. The Expected Annual Volume Is 4 Doses, Each Corresponding To The Amount Of Drug Administered To One Patient According To Their Individual Needs (One Or More Inj. Vials In A Specific Ratio), Atc L01xl08. The Dose Means An Individually Determined Amount Of Drug That Corresponds To A One -Off Application To A Specific Patient Based On Their Current Need, Regardless Of The Number/Type 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 Diffuse Large Cell B-Lymphoma (Diffuse Large B-Cell Lymphoma, Dlbcl), B-Cell Lymphoma Lymphoma (High Grade B-Cell Lymphoma, Hgbcl) B-Lymphoma (Primary Mediastinal Large B-Cell Lymphoma, Pmbcl) And Follicular Lymphoma 3B (Follicular Lymphoma Grade 3B, Fl3b) In Which Relapse Of The Disease Within 12 Months After The End Of Chemoimunotherapy Patients With Relapive Or Refractory Dlbcl, Pmbcl And Fl3b After Two Or More Lines Of Systemic Therapy. In View Of The Fact That The Production Of 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 Product, Ensuring The Quality Of The Product, Process Records, 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.
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