XARELTO

This brand name is authorized in Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

Active ingredients

The drug XARELTO contains one active pharmaceutical ingredient (API):

1 Rivaroxaban UNII 9NDF7JZ4M3 - RIVAROXABAN

Rivaroxaban is a highly selective direct factor Xa inhibitor with oral bioavailability. Inhibition of factor Xa interrupts the intrinsic and extrinsic pathway of the blood coagulation cascade, inhibiting both thrombin formation and development of thrombi. Rivaroxaban does not inhibit thrombin (activated factor II) and no effects on platelets have been demonstrated. Read about Rivaroxaban

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
XARELTO 10mg Film-coated tablet	European Medicines Agency (EU)	MPI, EU: SmPC
XARELTO 15mg Film-coated tablet	European Medicines Agency (EU)	MPI, EU: SmPC
XARELTO 15mg/20mg Film-coated tablet	European Medicines Agency (EU)	MPI, EU: SmPC
XARELTO 2.5mg Film-coated tablet	European Medicines Agency (EU)	MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
B01AF01		B Blood and blood forming organs → B01 Antithrombotic agents → B01A Antithrombotic agents → B01AF Direct factor Xa inhibitors
Discover more medicines within B01AF01

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: AU	Pharmaceutical Benefits Scheme	Identifier(s): 11633G, 12192Q, 12197Y, 2160Q, 2268J, 2691P, 9465E, 9466F, 9467G, 9468H, 9469J
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 538901201110211, 538901202117211, 538901203113218, 538901204111219, 538912030010002, 538912030010102, 538912030010202, 538912030010302, 538912030010402, 538912030010502, 538912030010602, 538912030010702, 538912030010802, 538912030010902, 538912030011002, 538912030011102, 538912030011202, 538912030011302, 538912030011402, 538912030011502, 538920030029807, 538920030029907
Country: CA	Health Products and Food Branch	Identifier(s): 02316986, 02378604, 02378612, 02480808
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 204-MEE-0414, 29534-12-10, 360020412, 360030412, 4848-MEE-1019
Country: EE	Ravimiamet	Identifier(s): 1381654, 1381665, 1381676, 1381687, 1552586, 1552597, 1552609, 1552610, 1552621, 1552632, 1552654, 1552665, 1552676, 1552687, 1552698, 1622595, 1622607, 1622618, 1622629, 1622630, 1622641, 1622652, 1622663, 1622674, 1660799, 1744893, 1744949, 1773648, 1773659, 1773660, 1837896, 1837908
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 08472006, 08472007, 08472008, 08472012, 08472013, 08472016, 08472018, 08472021, 108472027, 108472033
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 061009, 104449, 124105, 131851, 131863, 138007, 139013, 169845, 390283, 461217, 578944, 594353
Country: FR	Base de données publique des médicaments	Identifier(s): 60393661, 65763132, 67071218, 69800507
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 142374, 142375, 142376, 198409, 198410, 198411, 198415, 198416, 234038, 271604, 347929, 347932, 369085, 379989, 379991, 391353, 395051, 395052
Country: HK	Department of Health Drug Office	Identifier(s): 57861, 61395, 61396, 65785, 65786, 65787, 66373
Country: IE	Health Products Regulatory Authority	Identifier(s): 13230, 53335, 53336, 53337, 53342, 53356, 53357
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 6408, 6948, 6949, 8100, 9375, 9376
Country: IT	Agenzia del Farmaco	Identifier(s): 038744013, 038744025, 038744037, 038744049, 038744052, 038744064, 038744076, 038744088, 038744090, 038744102, 038744114, 038744126, 038744138, 038744140, 038744153, 038744165, 038744177, 038744189, 038744191, 038744203, 038744215, 038744227, 038744239, 038744241, 038744254, 038744266, 038744278, 038744280, 038744292, 038744304, 038744316, 038744328, 038744330, 038744342, 038744355, 038744367, 038744379, 038744381, 038744393, 038744405, 038744417, 038744429, 038744431, 038744443, 038744456, 038744468, 038744470, 038744482, 038744494, 038744506, 038744518
Country: JP	医薬品医療機器総合機構	Identifier(s): 3339003C1028, 3339003C2024, 3339003F1024, 3339003F2020, 3339003F3027, 3339003F4023, 3339003F5020, 3339003R1020, 3339003R2027
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1034484, 1034485, 1034486, 1034487, 1034488, 1034489, 1034490, 1034491, 1058057, 1058058, 1064341, 1064342, 1064343, 1064344, 1064345, 1064346, 1064347, 1064348, 1064349, 1064350, 1064351, 1070407, 1070408, 1070409, 1074842, 1074843, 1074844, 1074845, 1074846, 1074847, 1074848, 1074849, 1074850, 1074851, 1074852, 1078877, 1078878, 1080638, 1080639, 1083153, 1084328, 1084329, 1084330, 1084331, 1084332, 1084941, 1084942, 1084943, 1084944, 1091778, 1091779
Country: MX	Comisión Federal para la Protección contra Riesgos Sanitarios	Identifier(s): 357M2008
Country: NG	Registered Drug Product Database	Identifier(s): A4-6191, B4-2093, C4-1332
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 100145, 100153, 117250, 197289, 88862
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 13824, 14910, 14911, 21203
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100197577, 100258497, 100258586, 100313240, 100387007, 100453428
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W63896001, W63896002, W63896003, W63896004, W63896005, W63896006, W63896007, W63896008, W63897001, W63898001, W64154001
Country: SG	Health Sciences Authority	Identifier(s): 13567P, 14118P, 14119P, 14455P
Country: TN	Direction de la Pharmacie et du Médicament	Identifier(s): 8363021, 8363022, 8363023, 8363024, 8363025
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699546090174, 8699546090181, 8699546093885, 8699546093892, 8699546093908, 8699546094097, 8699546094103, 8699546094110, 8699546094127
Country: US	FDA, National Drug Code	Identifier(s): 50090-3625, 50090-3639, 50090-4468, 50090-4469, 50458-577, 50458-578, 50458-579, 50458-580, 55154-1422, 55154-1423, 55154-1424
Country: ZA	Health Products Regulatory Authority	Identifier(s): 42/8.2/1046, 46/8.2/0111, 46/8.2/0112