Draft PRODUCT INFORMATION - Medsafe

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140416 NEXAVAR data sheet Page 1 of 25 Data Sheet N E X AVA R Sorafenib tosylate Tablets, film-coated 200 mg name of the medicine NEXAVAR is a multikinase inhibitor targeting several serine/threonine and receptor tyrosine kinases. Sorafenib tosylate is 4-(4-{3-[4-Chloro-3- (trifluoromethyl)phenyl]-ureido}phenoxy) -N2-methylpyridine-2- carboxamide 4-methylbenzenesulfonate. The empirical formula is C21H16ClF3N4O3 x C7H8O3S and the CAS number is 28844-1- 73-01 (sorafenib) and 475207-59-1 (sorafenib tosylate). Sorafenib tosylate has the following structural formula: NHNHOONNHCH3OClFFFCH3SOOHO Description Sorafenib tosylate is a white to yellowish or brownish solid with a molecular weight of 637 g/mol. Sorafenib tosylate is practically insoluble in aqueous media, slightly soluble in ethanol and soluble in PEG 400.

140416 NEXAVAR data sheet Page 1 of 25 Data Sheet . NEXAVAR ® Sorafenib tosylate Tablets, film-coated 200 mg . Name of the Medicine . NEXAVAR is a multikinase inhibitor targeting several serine/threonine and receptor

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