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Issuing CEFTA Economy
Serbia
BTI Reference
1839/17
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 liofilizovanog praha, upakovanog u staklenu bocicu, koja se uz uputstvo za upotrebu isporucuje u kartonskoj kutiji sa naštampanom proizvodackom deklaracijom. Proizvod sadrži pembrolizumab (humanizovano monoklonsko antitelo) 50 mg, kao aktivnu komponentu, i pomocne supstance: polisorbat 80, L-histidin i saharozu. Nakon rekonstitucije, 1 ml rastvora sadrži 25 mg pembrolizumaba. Koristi se za lecenje uznapredovalog (neresektabilnog ili metastatskog) melanoma, kod odraslih. Primenjuje se putem intravenske infuzije, nakon rekonstitucije dodatkom vode za injekcije.
National keywords
Imunološki proizvod (lek)
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