EU Binding Tariff Information
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BTI Reference :
Issuing Country : DENMARK
Date Of Issue : 18.Oct.2018 - 17.Oct.2021
Ozempic pre-filled pen with insulin solution for diabetes treatment, including needles for use with disposable needles
Description auto translated : The product is insulin solution in pack for retail sale. The insulin solution is placed in a pre-filled pen with dose setting. Needles included in the package. The product is a medicine for diabetes (diabetes) used in combination with diet and exercise for the treatment of adults whose type 2 diabetes is insufficiently regulated. The medicine is contained in a pen with dose setting intended for use with disposable needles. The product consists of a colorless insulin solution for injection contained in a pre-filled pen with dose setting. Needles included in the package. Ozempic (Semaglutid) contains an artificial version of the natural hormone that naturally occurs in the body and releases into the intestine when you eat. Human GLP-1 analogue is prepared in Saccharomyces cerevisiae cells by recombinant DNA technology. Semaglutide is classified according to ECICS in product code 29371900, ie. before it is formulated and packaged for a drug. By wording is meant the process in which various chemical substances, including the active drug, are combined to produce a final drug. Besides Semaglutide, Ozempic® consists of disodium phosphate dihydrate, propylene glycol, phenol, water for injections and sodium hydroxide / hydrochloric acid (for pH adjustment).
Original Description: Varen er insulinopløsning i pakning til detailsalg. Insulinopløsningen er placeret i en præfyldt injektionspen med dosisindstilling. Nåle medfølger i pakken.Varen er et lægemiddel mod diabetes (sukkersyge), der anvendes sammen med kost og motion til behandling af voksne, hvis type 2-diabetes ikke er tilstrækkeligt reguleret. Lægemidlet er indeholdt i en pen med dosisindstilling beregnet til anvendelse sammen med engangsnåle.Varen består af en farveløs insulinopløsning til injektion indeholdt i en fyldt pen med dosisindstilling. Nåle medfølger i pakken.Ozempic (Semaglutid) indeholder en kunstig version af det naturlige hormon, som naturligt forekommer i kroppen og frigives i tarmen, når man spiser. Human GLP-1-analog er fremstillet i Saccharomyces cerevisiae-celler ved rekombinant dna-teknologi.
Semaglutide tariferes jf. ECICS i varekode 29371900, dvs. før det formuleres og pakkes til et lægemiddel. Ved formulering forstås den proces, hvor forskellige kemiske stoffer, herunder det aktive lægemiddel, kombineres til fremstilling af et endeligt lægemiddel. Udover Semaglutide består Ozempic® af Dinatriumphosphatdihydrat, propylenglycol, phenol, vand til injektionsvæsker og natriumhydroxid/saltsyre (til pH-justering).
Source : EU Binding Tariff Information
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