The subject of the order is the delivery of medicinal products containing sacubitryl/valsartan and enalapril at a dose not available on the Polish market (Package No 1 and No 2) and the manufacture of placebo for the medicinal products above, and the repackaging, labelling, exemption to the clinical trial by A person qualified for the implementation of a clinical trial entitled “Noncommercial Clinical Trial - Sakubitril/valsartan for the treatment of pulmonary hypertension secondary to heart failure with reduced ejection fraction — PRESENT-HF Study” as part of a competition for research and development activities in scope of non-commercial clinical trials No 2019/ABM/01/00078.
Package No. 1Medicinal products purchased for the purposes of a clinical trial. Sacubitril/valsartan - dose of 24 mg + 26 mg Purple-white, oval, bilaterally convex film-coated tablet with truncated edges, without dividing lines. Packager=28 tabl. - 6728 packs
Package No. 2Medicinal products purchased for the purposes of a clinical trial. Enalapril 2.5 mg - Tablet, white, round, biconvex, without excision (dividing line). Packager=30 tabl. - 6280 packs
Package No. 3Manufacture of placebo for medicinal products containing sacubitrile/valsartan 24 mg + 26mg, for medicinal products containing enalapril at a dose of 2,5 mg and repackaging, labelling, exemption to clinical trial by a Qualified Person, for a period of 48 months.