PRADAXA

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, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Tunisia, Turkey, UK.

Active ingredients

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

1	Dabigatran UNII SC7NUW5IIT - DABIGATRAN ETEXILATE MESYLATE
	Dabigatran etexilate is a small molecule prodrug which does not exhibit any pharmacological activity. After oral administration, dabigatran etexilate is rapidly absorbed and converted to dabigatran by esterase-catalysed hydrolysis in plasma and in the liver. Dabigatran is a potent, competitive, reversible direct thrombin inhibitor and is the main active principle in plasma.
	Read more about Dabigatran

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
PRADAXA 150mg Hard capsule	MPI, EU: SmPC	European Medicines Agency (EU)
PRADAXA 110mg Hard capsule	MPI, EU: SmPC	European Medicines Agency (EU)
PRADAXA 75mg Hard capsule	MPI, EU: SmPC	European Medicines Agency (EU)
PRADAXA Coated granules	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
B01AE07	Dabigatran etexilate	B Blood and blood forming organs → B01 Antithrombotic agents → B01A Antithrombotic agents → B01AE Direct thrombin inhibitors
Discover more medicines within B01AE07

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	2753X, 2769R, 9318K, 9319L, 9320M, 9321N, 9322P, 9323Q
BR	Câmara de Regulação do Mercado de Medicamentos	504505101119316, 504505102115314, 504505103111312, 504505104118310, 504505105114319, 504505106110317, 504505107117315, 504505108113313
CA	Health Products and Food Branch	02312433, 02312441, 02358808
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	28863-05-09, 28864-05-09, 30190-05-12
EE	Ravimiamet	1343359, 1343360, 1343371, 1343382, 1343393, 1343405, 1538726, 1538737, 1538748, 1538759, 1538760, 1587258, 1587269
ES	Centro de información online de medicamentos de la AEMPS	08442002, 08442003, 08442005, 08442006, 08442007, 08442011
FI	Lääkealan turvallisuus- ja kehittämiskeskus	115330, 115341, 115364, 442705
FR	Base de données publique des médicaments	63484283, 65570603, 65693901
GB	Medicines & Healthcare Products Regulatory Agency	135048, 135051, 135055, 135056, 194659, 368206, 368212, 375293, 375296
HK	Department of Health Drug Office	57315, 57316, 60516
IE	Health Products Regulatory Authority	36882, 36883, 60602, 60603, 60612, 60615, 60616, 60617, 60628, 60633, 60634, 60659, 60681, 60684, 60685
IL	מִשְׂרַד הַבְּרִיאוּת	6317, 6318, 6319, 6320, 6321, 6685
IT	Agenzia del Farmaco	038451011, 038451023, 038451035, 038451047, 038451062, 038451074, 038451086, 038451098, 038451100, 038451112, 038451124, 038451136, 038451148, 038451201, 038451213, 038451225, 038451237, 038451249, 038451252, 038451264
LT	Valstybinė vaistų kontrolės tarnyba	1031768, 1031769, 1031770, 1031771, 1031772, 1031773, 1031774, 1031775, 1061808, 1061809, 1061810, 1061811, 1061812, 1061815, 1067398, 1067399, 1067400, 1067401, 1067402, 1091757, 1091758, 1091759, 1091760, 1091761, 1091762, 1091763
NL	Z-Index G-Standaard, PRK	86983, 86991, 98361
NZ	Medicines and Medical Devices Safety Authority	13118, 13119, 14318
PL	Rejestru Produktów Leczniczych	100191706, 100191712, 100250679, 100455414, 100455421, 100455446, 100455453, 100455460, 100455478, 100455485
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W52942001, W52942002, W52942003, W52942004, W52943001, W52943002, W52943003, W52943004, W52943005, W57151001, W57151002, W57151003, W57151004, W57151005, W69037001, W69038001, W69039001, W69040001, W69041001, W69042001, W69043001
SG	Health Sciences Authority	13697P, 13698P, 13941P
TN	Direction de la Pharmacie et du Médicament	11533041, 11533042, 11533043
TR	İlaç ve Tıbbi Cihaz Kurumu	8699693150042, 8699693150059, 8699693150097, 8699693150103, 8699693150127
US	FDA, National Drug Code	0597-0108, 0597-0355, 0597-0360, 50090-3617, 50090-4480, 63629-8242
ZA	Health Products Regulatory Authority	42/8.2/0130, 42/8.2/0131, 45/8.2/0162