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Issuing CEFTA Economy
Serbia
BTI Reference
1838/17
Validity Start Date
19/01/2017
Validity End Date
19/01/2020
Nomenclature code
3002150000
Justification
Language
Српски језик
Issuing place
Beograd
Issuing date
Goods description
Imunološki proizvod (lek), pripremljen u pakovanju za prodaju na malo. Predmetna roba je u vidu rastvora za injekciju, kojim je napunjen špric (sa iglom) zapremine 0,5 ml, koji se uz uputstvo za upotrebu isporucuje u kartonskoj kutiji sa naštampanom proizvodackom deklaracijom. Proizvod sadrži golimumab (ljudsko IgG1k monoklonsko antitelo) 50 mg, kao aktivnu komponentu, i pomocne supstance: sorbitol, polisorbat 80, L-histidin i vodu za injekcije. Primenjuje se supkutano, u lecenju reumatoidnog i psorijaticnog artritisa, ankilozirajuceg spondilitisa i ulceroznog kolitisa, kod odraslih osoba. Terapeutsko dejstvo leka (pripada grupi „TNF blokatora“) se zasniva na sprecavanju delovanja proteina TNFa, koji ucestvuje u zapaljenskim procesima u organizmu.
National keywords
Imunološki proizvod (lek)
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