XARELTO

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

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 more about Rivaroxaban

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

ATC Group		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)
AU	Pharmaceutical Benefits Scheme	11633G, 12192Q, 12197Y, 2160Q, 2268J, 2691P, 9465E, 9466F, 9467G, 9468H, 9469J
BR	Câmara de Regulação do Mercado de Medicamentos	538901201110211, 538901202117211, 538901203113218, 538901204111219, 538912030010002, 538912030010102, 538912030010202, 538912030010302, 538912030010402, 538912030010502, 538912030010602, 538912030010702, 538912030010802, 538912030010902, 538912030011002, 538912030011102, 538912030011202, 538912030011302, 538912030011402, 538912030011502, 538920030029807, 538920030029907
CA	Health Products and Food Branch	02316986, 02378604, 02378612, 02480808
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	204-MEE-0414, 29534-12-10, 360020412, 360030412, 4848-MEE-1019
EE	Ravimiamet	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
ES	Centro de información online de medicamentos de la AEMPS	08472006, 08472007, 08472008, 08472012, 08472013, 08472016, 08472018, 08472021, 108472027, 108472033
FI	Lääkealan turvallisuus- ja kehittämiskeskus	061009, 104449, 124105, 131851, 131863, 138007, 139013, 169845, 390283, 461217, 578944, 594353
FR	Base de données publique des médicaments	60393661, 65763132, 67071218, 69800507
GB	Medicines & Healthcare Products Regulatory Agency	142374, 142375, 142376, 198409, 198410, 198411, 198415, 198416, 234038, 271604, 347929, 347932, 369085, 379989, 379991, 391353, 395051, 395052
HK	Department of Health Drug Office	57861, 61395, 61396, 65785, 65786, 65787, 66373
IE	Health Products Regulatory Authority	13230, 53335, 53336, 53337, 53342, 53356, 53357
IL	מִשְׂרַד הַבְּרִיאוּת	6408, 6948, 6949, 8100, 9375, 9376
IT	Agenzia del Farmaco	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
JP	医薬品医療機器総合機構	3339003C1028, 3339003C2024, 3339003F1024, 3339003F2020, 3339003F3027, 3339003F4023, 3339003F5020, 3339003R1020, 3339003R2027
LT	Valstybinė vaistų kontrolės tarnyba	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
MX	Comisión Federal para la Protección contra Riesgos Sanitarios	357M2008
NG	Registered Drug Product Database	A4-6191, B4-2093, B4-4878, C4-1332
Switch country to Nigeria in order to find specific presentations of XARELTO
NL	Z-Index G-Standaard, PRK	100145, 100153, 117250, 197289, 88862
NZ	Medicines and Medical Devices Safety Authority	13824, 14910, 14911, 21203
PL	Rejestru Produktów Leczniczych	100197577, 100258497, 100258586, 100313240, 100387007, 100453428
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W63896001, W63896002, W63896003, W63896004, W63896005, W63896006, W63896007, W63896008, W63897001, W63898001, W64154001
SG	Health Sciences Authority	13567P, 14118P, 14119P, 14455P
TN	Direction de la Pharmacie et du Médicament	8363021, 8363022, 8363023, 8363024, 8363025
TR	İlaç ve Tıbbi Cihaz Kurumu	8699546090174, 8699546090181, 8699546093885, 8699546093892, 8699546093908, 8699546094097, 8699546094103, 8699546094110, 8699546094127
US	FDA, National Drug Code	50090-3625, 50090-3639, 50090-4468, 50090-4469, 50458-577, 50458-578, 50458-579, 50458-580, 55154-1422, 55154-1423, 55154-1424
ZA	Health Products Regulatory Authority	42/8.2/1046, 46/8.2/0111, 46/8.2/0112