ZP/91/2026 Sukcesywna dostawa produktu leczniczego na potrzeby badania klinicznego realizowanego w projekcie "B cell depletion therapy to improve outcomes of steroid-sensitive nephrotic syndrome in adults-BOOSTER Trial”

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The subject of the contract is the successive supply of a medicinal product for the needs of a clinical trial carried out under the project “B cell depletion therapy to improve outcomes of steroid-sensitive nephrotic syndrome in adults-BOOSTER Trial”. ”, funded from the resources of the Medical Research Agency under the ABM/2023/1 competition. The delivery of medicinal products shall be carried out in accordance with the principles of GCP, GMP and GDP. The subject of the contract includes: 1. Purchase of the medicinal product Rituximab (brand name: RIXIMYO), Concentrate for the preparation of an infusion solution, 10 mg/ml (500 mg), 1 vial 50 ml, in the quantity: 150 vials, with a shelf life of at least 14 months from the date of delivery of the product. The medicinal product containing the active substance Rituximab must be approved for trading within the European Union. The Summary of Product Characteristics for the medicinal product containing the active substance Rituximab should include information on the possibility of using an alternative dosing regimen involving the administration of a second and subsequent infusions at a higher infusion rate using a drug solution with…

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